← Product Code [IYE](/productcode/IYE) · K946074

# ALDERSON BREST DOSIMETRY SYSTEM (K946074)

_Radiology Support Devices, Inc. · IYE · Dec 21, 1995 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K946074

## Device Facts

- **Applicant:** Radiology Support Devices, Inc.
- **Product Code:** [IYE](/productcode/IYE.md)
- **Decision Date:** Dec 21, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

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**Source:** [https://fda-staging.innolitics.com/device/K946074](https://fda-staging.innolitics.com/device/K946074)

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